The Effectiveness of Rehabilitation Training Based on Brain-computer Interface Technology to Improve the Upper Limb Motor Function of Ischemic Stroke.

Last updated: February 19, 2024
Sponsor: Beijing Tiantan Hospital
Overall Status: Completed

Phase

N/A

Condition

Thrombosis

Stroke

Cerebral Ischemia

Treatment

Brain-computer interface

Traditional rehabilitation

Clinical Study ID

NCT04387474
KY2019-089-02
  • Ages 18-80
  • All Genders

Study Summary

To evaluate the effectiveness and safety of rehabilitation training based on brain-computer interface in improving the upper motor function, self-care ability in daily life and quality of life in patients with ischemic stroke. This study adopts centralized uniform random 1:1 grouping, subjects will be randomly assigned to the experimental group and the control group. Randomization schemes are generated by statistical professionals using SAS software.

Eligibility Criteria

Inclusion

Inclusion Criteria:

  1. Adult subjects (18 years<male or female≤80 years )
  2. Ischemic stroke diagnosed by MRI within 1 month before randomization
  3. Unilateral upper limb dysfunction with NIHSS score 1-3 at the time of randomization
  4. Informed consent signed

Exclusion

Exclusion Criteria:

  1. Unable to understand or cooperate because of severe aphasia or cognitive impairment (CDR >0.5) or mental illness
  2. A history of epilepsy
  3. Sensory disorders or hallucinations
  4. Internal carotid artery dissection or thrombolysis
  5. Apraxia
  6. Agnosia
  7. Other diseases that may interfere with motor function
  8. Severe cardiopulmonary disease, severe illness, and unstable vital signs
  9. Severe balance dysfunction
  10. Participating in other clinical trial
  11. During pregnancy and lactation
  12. The Numerical Rating Scale (NRS) scores of upper extremities>4.

Study Design

Total Participants: 300
Treatment Group(s): 2
Primary Treatment: Brain-computer interface
Phase:
Study Start date:
May 10, 2020
Estimated Completion Date:
May 31, 2022

Study Description

Brain computer interface(BCI) is a noninvasive nervous system intervention. As a new method, it is applied in rehabilitation by stimulating peripheral nerve, such as motor, vibration, sensory, in combination with other stimulations, such as transcranial magnetic stimulation, transcranial electrical stimulation, etc.

In traditional rehabilitation therapy, hand-holding training is completed by physical therapist. Rehabilitation robot is also used for auxiliary training. BCI therapy will stimulate patients to take part in rehabilitation training more actively and obtain better effects on the rehabilitation of stroke.

Connect with a study center

  • China National Clinical Research Center for Neurological Diseases

    Beijing, Beijing 100070
    China

    Site Not Available

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